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NEW YORK–(HSMN NewsFeed)–Paradigm Spine, LLC, a developer of innovative non-fusion spinal implant solutions, announced that it has completed a $21.5 million financing, consisting of a $15mm debt facility and $6.5mm equity. Fifth Third Bank was the sole lender in the $15mm venture debt funding. The $6.5 mm of equity was led by Praefinium Group, a global asset management group specializing in high-growth opportunities, and Trevi Health Ventures, a venture capital firm specializing in healthcare investments.
The proceeds from this financing will be used to strengthen the US sales infrastructure, fund the Company’s ongoing US clinical trial of the coflex® device, and drive further international expansion of the company’s product portfolio. The Company believes this financing will carry it through to profitability in 2010.

Marc R. Viscogliosi, Chairman and CEO of Paradigm Spine, LLC, said “Paradigm’s ability to raise capital despite this current economic situation reinforces the strength and quality of our organization, and the confidence our investors have in the success of the company. Paradigm has demonstrated a strong track record over the past 4 years, with sales growing at a CAGR of over 60% from 2005 – 2008. Worldwide revenues grew 63% 2Q09 vs. 2Q08 and growth was more than 15% when comparing sequentially 2Q09 vs. 1Q09. We are particularly pleased with this performance despite economic headwinds and slowing surgical volumes and expect this growth to continue with the expansion of the US Sales team. ”

Jeff Thieman, vice president of National Healthcare Finance at Fifth Third Bank added: “We are pleased to do business with a market leader in the advancement of innovative non-fusion spinal implant products. The new capital will support Paradigm as the Company positions itself for future growth. At Fifth Third Bank, we are committed to responsible lending for our commercial clients.”

HealthCor Partners has been an investor since 2007 and is a significant shareholder of Paradigm Spine. Jeff Lightcap, Senior Managing Director at HealthCor and a member of the Paradigm Board said “HealthCor has watched the compelling value proposition of Paradigm Spine increase over the past few years, from a small, R&D focused product development company to an established operational business with a full product portfolio. We believe this financing will take the Company even further to the next level, enabling achievement of significant sales, clinical and regulatory milestones in the next few years.”

Paradigm Spine is also pleased to announce the promotion of Matt Stuttle to the position of Vice President, US Sales. Matt joined Paradigm Spine in June of 2008 as an Area Sales Director for the Western US with over 12 years of Pharmaceutical and Medical Device experience. He has held various positions in Sales, Sales Management, and Director level roles with Forest Pharmaceuticals, Kyphon, and most recently Medtronic Spine and Biologics.

“Promoting Matt to Vice President, US Sales, creates a results oriented culture and strong foundation for our US Sales team,” commented Chris Hughes, President, US. “He will continue to add extensive industry knowledge, surgeon and sales force relationships to the US infrastructure, and he will be instrumental in strategically executing our US sales plan.”

MINNEAPOLIS – July 23, 2009 – Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified its voluntary recall action of the Intrepid™ Intervertebral Body Fusion Device as a Class II recall. Medtronic initiated a voluntary recall of the product on February 6, 2009, and communicated the risk to physicians and hospitals. As of the date of this news release, all unused product has been retrieved and Medtronic has received confirmation of notification from all affected physicians and hospitals.

The Intrepid™ Intervertebral Body Fusion Device is intended to provide stabilization of the vertebral bodies and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine.  There were approximately 650 surgeries performed using this device for which Medtronic has received 12 complaints.  The most notable of these were:

• Three reports where the device was used in patients with poor bone quality and/or gross translational instability, leading to the need for revision surgery.  An adverse event associated with one of these revision surgeries was a patient death;
• Four reports of difficulty in attaching the implant cover plate; and
• One case of cover plate detachment.

The device was recalled because, upon review of the clinical experience, Medtronic had determined that there was a need to revise the labeling and modify the device design.  Medtronic will be updating the labeling to reinforce that: 

• Patient selection relative to both bone quality and stability is an important consideration for the proper application of this device;
• The Intrepid™ Intervertebral Body Fusion device requires the use of either three screws or supplemental fixation; and
• The integral cover plate must be used to reduce the potential for screw back out.

In addition, due to problems associated with cover plate attachment difficulties cited above, Medtronic has developed a new design intended to improve the ergonomics of cover plate attachment.  The 510(k) submission for those modifications is currently under FDA review.

Medical assessment indicates that use of the device without adherence to the labeling criteria listed above or without a cover plate creates a risk that the implant could become unstable which could, in turn, possibly lead to the need for revision surgery.  Given the close proximity of major blood vessels in the lumbar spine region, such revision surgery has the potential for serious complications.

The FDA’s classification of the voluntary recall does not alter Medtronic’s patient management recommendations as provided in the April 30, 2009 letter to physicians and risk managers:

• For implanted patients where patient bone quality or stability may have been questionable, or where the cover plate was not used, Medtronic is recommending that device stability and screw anchoring be assessed during regular post-operative follow-up visits. These patients should be closely monitored for any signs of early migration.  In the rare cases where migration occurs, it is typically within the first four months following surgery.
• Medtronic is not recommending removal of the Intrepid™ Intervertebral Body Fusion device unless it is warranted in the medical judgment of the physician.  

BY LAUREN UZDIENSKI, JULY 22, 2009

This month JBJS published a review entitled “What’s New in Spine Surgery.” We’ve summarized some of the highlights below.

Positive Outcomes for Cervical Disc Arthroplasty

• In two recent studies, arthroplasty was associated with equal or greater pain relief and functional outcomes when compared to fusion and discectomy. Adverse events were similar in both groups, with fewer reoperations in the arthroplasty group. Satisfactory outcomes were maintained at four years in both the arthroplasty and fusion groups.
  

Biologics Show Promise, But Development is Slow

• BMPs: Results have been “inconsistent” in studies of DePuy’s GDF-5. BMP-7 (Stryker’s OP-1) is reportedly still under review by the FDA, and it has been suggested that the current concentration of the BMP may be insufficient for spinal fusion. BMP-2 (Medtronic’s Infuse) has performed well in studies, but concerns remain about adverse events, particularly in the cervical spine.
  
• Bone graft substitutes: Mesenchymal stem cells remain an area of interest, though the amount of cells needed to elicit a bone-healing response as well as what triggers need to be expressed by the cells is unknown.
  
• Disc degeneration: biologic treatments in this space are developing at a “slow pace,” though a human trial evaluating BMP delivery to discs to prevent degeneration is in development.
  

New Technologies, New Patients for Lumbar Spine Procedures

• SPORT: Compared to nonsurgical treatment, surgical treatment resulted in better outcomes for all patients in the study. Compared to patients with primary back pain, patients with primary leg pain improved more with surgical treatment.
  
• Surgery in the elderly: Higher complication rates are observed in this population, though one recent study demonstrated the “substantial benefits” associated with fusion in this group.
  
• New technology: In one study comparing Zimmer’s Dynesys, a pedicle-based dynamic stabilization system, with lumbar posterolateral fusion, the dynamic stabilization group reported a greater improvement in leg pain and back pain scores when compared to fusion, though overall results in both groups were comparable. A separate study evaluating Dynesys found that 20% of patients receiving the device required re-operation at two years. 39% of these cases were attributable to screw loosening, with additional complications including screw breakage and cephalad spinal stenosis.
  

NEW BRUNSWICK, N.J., July 14, 2009 /PRNewswire-FirstCall via COMTEX News Network/ — Johnson & Johnson (NYSE: JNJ) today announced sales of $15.2 billion for the second quarter of 2009, a decrease of 7.4% as compared to the second quarter of 2008. Operational results declined 1.4% and the negative impact of currency was 6.0%. Domestic sales declined 6.7%, while international sales declined 8.0%, reflecting operational growth of 3.9% and a negative currency impact of 11.9%.

Net earnings and diluted earnings per share for the second quarter of 2009 were $3.2 billion and $1.15, respectively. The second quarter of 2008 included an after-tax in-process research and development charge of $40 million. Excluding this charge, net earnings for the quarter and diluted earnings per share represent decreases of 4.7% and 2.5%, respectively, as compared to the same period in 2008.* The Company confirmed its earnings guidance for full-year 2009 of $4.45 – $4.55 per share, which excludes the impact of special items.

“I am proud of the accomplishments of our people in continuing to deliver very solid operational results in light of the significant impacts of patent expirations and the economic environment,” said William C. Weldon, Chairman and Chief Executive Officer. “Our investments through internal research and development, strategic partnerships and acquisitions have allowed us to build what is considered by many to be one of the best pipelines in our industry. We will continue to invest in our portfolio of innovative products to meet the needs of patients and consumers around the world.”

Worldwide Consumer sales of $3.9 billion for the second quarter represented a decrease of 4.5% versus the prior year with an increase of 3.1% operationally and a negative impact from currency of 7.6%. Domestic sales increased 0.8%; while international sales decreased 8.4%, which reflected an operational increase of 4.7% and a negative currency impact of 13.1%.

LISTERINE(R) antiseptic mouthrinse and the skin care lines of NEUTROGENA(R) and AVEENO(R) contributed to operational sales growth during the quarter. Other growth drivers were sales from the recently completed acquisition of the French company Vania Expansion SNC.

Worldwide Pharmaceutical sales of $5.5 billion for the second quarter represented a decrease versus the prior year of 13.3% with an operational decline of 8.5% and a negative impact from currency of 4.8%. Domestic sales decreased 16.4%; while international sales decreased 8.7%, which reflected an operational increase of 3.3% and a negative currency impact of 12.0%.

REMICADE(R) (infliximab), a biologic approved for the treatment of a number of immune mediated inflammatory diseases; PREZISTA(R) (darunavir), a treatment for HIV; VELCADE(R) (bortezomib), a treatment for multiple myeloma; and CONCERTA(R) (methylphenidate HCI), a treatment for attention deficit hyperactivity disorder, had strong operational sales performance during the quarter. Sales results of TOPAMAX(R) (topiramate), an anti-epileptic, and RISPERDAL(R) (risperidone), an antipsychotic medication, were negatively impacted by generic competition.

During the quarter, the U.S. Food and Drug Administration (FDA) approved SIMPONI(TM) (golimumab) for the treatment of adults with moderately to severely active rheumatoid arthritis in combination with methotrexate, active psoriatic arthritis with or without methotrexate, and active ankylosing spondylitis. The FDA also approved the Supplemental New Drug Applications (sNDAs) for the use of RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Treatment as both monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of Bipolar I Disorder. The Drug Enforcement Administration (DEA) issued their final ruling and placed NUCYNTA(TM) (tapentadol) CII immediate release tablets for the relief of moderate to severe acute pain in patients 18 years of age or older into Schedule II of the Controlled Substances Act. The product is now available to patients.

The Company also announced a definitive agreement to acquire Cougar Biotechnology, a development stage biopharmaceutical company with a specific focus on oncology, for approximately $1.0 billion in a cash tender offer. On July 9, 2009, the acquisition of Cougar Biotechnology was completed. On July 2, 2009, the Company announced a definitive agreement with Elan Corporation, plc. whereby Johnson & Johnson will acquire substantially all of the assets and rights of Elan related to its Alzheimer’s Immunotherapy Program and will invest $1 billion in Elan newly issued American Depositary Receipts (ADRs).

Worldwide Medical Devices and Diagnostics sales of $5.9 billion for the second quarter represented a decrease of 3.1% versus the prior year with an operational increase of 2.9% and a negative currency impact of 6.0%. Domestic sales increased 1.9%; while international sales decreased 7.2%, which reflected an operational increase of 3.7% and a negative currency impact of 10.9%.

Primary contributors to the operational growth included Ethicon’s surgical care products; Ortho-Clinical Diagnostics’ professional products; Ethicon Endo-Surgery’s minimally invasive products; and DePuy’s orthopaedic joint reconstruction, spine, and sports medicine businesses. Also contributing to growth were sales of products acquired as part of the completed acquisition of Mentor Corporation, a leading supplier of medical products for the global aesthetic market. This growth was partially offset by lower sales in the Cordis franchise, reflecting new competitive entries in the drug-eluting stent market as well as the 2008 divestiture of the Professional Wound Care products in our Ethicon business